Keystone Dental Inc recalls Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are…

Recall date

September 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0299-2017

FDA classification

Class II

Brand / firm

Keystone Dental Inc

Sold / distributed

Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy

Why it was recalled

Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework